Kornimate/medical-research-clean huggingface dataset:
the open kinetic chain and closed kinetic chain strengthening exercises in degenerative meniscus tears

Conditions: Degenerative Disease; Meniscus Tear; Knee Pain Swelling

Summary: this randomized-controlled trial aims to compare the effect of open kinetic chain and closed kinetic chain strengthening exercises on pain, function, and health-related quality of life in degenerative meniscus tears.

patients with degenerative meniscus tears between the ages of 35 and 65 will be randomly divided into two groups: group 1 (open kinetic chain strengthening exercises) and group 2 (closed kinetic chain strengthening exercises). interventions will be applied for 16 sessions (twice a week for 8 weeks). the patients will be assessed at baseline and at the end of the 8-week intervention. the pain during activity, at rest, and at night will be assessed with the visual analog scale (vas). active range of motion will be assessed with a digital goniometer. isometric muscle strength will be measured with a handheld dynamometer. the functional status and symptoms will be evaluated by the knee injury and osteoarthritis outcome score (koos) and lysholm knee scoring scale. health-related quality of life will be assessed with the short form-12 (sf-12).

Eligibility criteria:
inclusion criteria: * being aged between 35 and 65 years * having the degenerative meniscus tear in at least one knee * having body mass index in the range of 18-30 kg/m2 * feeling the pain that lasts for at least 2 months * having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the mri results * access to the internet via a computer or smartphone * ability to read and write in turkish exclusion criteria: * having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear * participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks * have received steroid injections in the last 6 months * accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis * presence of any systemic disorder that may affect assessment parameters * any health condition that may prevent participation in physical activity or an exercise program (e.g., severe cardiovascular, respiratory, neurological, or musculoskeletal disorders) * failure to cooperate with assessments
patient-specific simulation used for evar procedure rehearsal - evaluation of clinical performance with and without prior rehearsal

Conditions: Infra Renal Aortic Aneurysm

Summary: the purpose of this study is to evaluate the procedural and clinical benefits of patient specific pre-procedure rehearsal for operators with various experience levels as a tool for optimizing endovascular aneurysm repair (evar) procedures.


Eligibility criteria:
inclusion criteria: 1. at least 18 years old 2. elective patients planned to undergo evar procedures with an endograft compatible with the simbionix prs. 3. computed tomography angiography (cta) scan of the abdominal aorta performed as standard of care. sufficient quality/defined protocol. exclusion criteria: 1. subject is below 18 years old 2. operator cannot complete the indicated rehearsal and practice. 3. patients requiring emergent aneurysm treatment, e.g. trauma or rupture. 4. arterial dissection. 5. patients with stage 4 of chronic kidney disease (gfr\<30 ml/min/m2). 6. patient is indicated for use of snorkels, chimneys, fenestrated or branched graft devices 7. pregnant or lactating women. 8. off label stent graft use

Keywords: elective endovascular aaa repair
clostridium histolyticum collagenase injection for urethral disease

Conditions: Urethral Stricture

Summary: the purpose of this study is to assess the efficacy of clostridium histolyticum collagenase (xiaflex®) in treating urethral strictures.

this is an open-label, pilot study to explore the efficacy of clostridium histolyticum collagenase (xiaflex®) in treating urethral strictures. subjects will be followed for 2 years from the initial drug treatment.

Eligibility criteria:
inclusion criteria: * males * age ≥ 18 years * failed prior proven conservative measures, including dviu or balloon dilation of the stricture will be included in this study * able and willing to undergo regular intervention as well as evaluation as described below will be included in the study * with a single stricture \<2cm in size that can be identified on retrograde urethrogram or voiding cystourethrogram will be included in the study. * must agree not to participate in a clinical study involving another investigational drug or device throughout the duration of this study * must be competent to understand the information given in irb approved icf and must sign the form prior to the initiation of any study procedure exclusion criteria: * has not yet undergone proven non-invasive measures, including dviu or balloon dilation. * multiple strictures or a single stricture larger than 2cm in size, measured with retrograde urethrogram, voiding cystourethrogram, or urethral ultrasonography. * corporal spongiosum tissues \< 5 mm in depth at proposed injection site * grade 5 spongiofibrosis * age \<18 * females * prior urethroplasty * urethral fistula * history of penile cancer, prostate cancer, or urinary tract malignancy (bladder, urethral, ureteral, or kidney). * history of radiation (external or brachytherapy) to the pelvic organs, penis or groin. * history of autoimmune or inflammatory bowel disease * contraindication to suprapubic tube placement * pre-procedure pvr \>250ml * allergy or sensitivity to chc * bleeding disorder or anticoagulant use other than aspirin up to 150mg/day * untreated urinary tract infection * inability to perform intermittent self-catheterization * participation in another clinical study or treatment with an investigational drug or device * serious or active medical or psychiatric condition which, in the opinion of the investigator, may interfere with treatment, assessment, or compliance with the protocol
intracapsular tonsillectomy in adults

Conditions: Tonsil Disease; Tonsillitis; Tonsillitis Acute; Tonsillitis Chronic

Summary: comparing the classical extracapsular tonsillectomy (te) performed with electrosurgery to intracapsular approaches (sipt) by coblation or microdebrider. the patient group is adults with recurrent or chronic tonsillitis

extracapsular tonsillectomy (te) with monopolar electrosurgery is the most commonly used approach in adult tonsil surgery in turku university central hospital, finland. in our study setting we are comparing intracapsular tonsillectomy (subtotal/intracapsular/partial tonsillectomy (sipt) ) as the intervention group with extracapsular tonsillectomy as the control group. sipt is done with either coblation or microdebrider and te with monopolar electrosurgery. indications for surgery are recurrent tonsillitis or chronic tonsillitis. the patient group is adults (16-65 years) safety, efficiency and cost-effectiveness are monitored in a prospective, patient-blinded and randomised study setting.

Eligibility criteria:
inclusion criteria: * age 16-65 years * planned tonsil surgery with informed consent * recurrent or chronic tonsillitis exclusion criteria: * less than 1 month old, drained quinsy * acute "hot phase" tonsillitis * previous palatine tonsil surgery * suspicion or confirmation of malignancy * high dose analgesics consumption * current cpap-device usage for treatment of osas * untreated gastro-esophageal reflux disease * anticoagulative medication * any condition of hemophilia * pregnancy, lactation * current or positive history of malignant disease (if still active follow-up)

Keywords: tonsil surgery tonsillectomy intracapsular microdebrider coblation extracapsular electrosurgery electrocautery adults
oseltamivir infant influenza safety study

Conditions: Influenza, Human

Summary: in june 2009, the world health organization (who) declared a global pandemic of influenza a (h1n1). although little is known about the pandemic influenza strain in children, during previous pandemics and influenza seasons children less than one year of age were shown to be at higher risk of influenza complications than older children. in light of the 2009 h1n1 pandemic situation, the u.s. food and drug administration (fda), european medicines agency (ema), and health canada issued emergency authorizations for oseltamivir to be used to treat and prevent influenza in infants under 1 year of age. it is anticipated that oseltamivir use in infants will dramatically increase due to the new authorizations for use in this population and high prevalence of h1n1 influenza circulating in the population. ongoing safety surveillance is critical and this study will provide further data for evaluating the risk/benefit ratio of prescribing oseltamivir to this population in the current milieu of both seasonal and pandemic influenza viruses circulating in the population. the study will also provide useful information on the dose and duration of treatment used in clinical practice and their relationship to adverse events.

this study is a prospective, observational, multicenter short-term safety study of the use of oseltamivir (prophylaxis or treatment) in children 24 months of age or younger. an internal comparator group of children diagnosed with influenza and not treated with antiviral medications will be enrolled. the study includes a 30-day follow-up period and will be conducted in multiple sites in multiple countries within the european union. the study will cover two consecutive influenza seasons: 01 october 2009 - 31 may 2010 and 01 october 2010 - 31 may 2011. data collection may be interrupted in the interim period between influenza seasons (june 1, 2010 - september 30, 2010), depending on whether the influenza season follows the expected cycle.

Eligibility criteria:
inclusion criteria: * 24 months of age or younger at time of enrollment * diagnosis of influenza a or b (suspected\* or confirmed by viral testing) either treated with oseltamivir or with no antivirals or prescribed oseltamivir for post-exposure influenza prophylaxis * parent/legal guardian willing to provide informed consent and be contacted by telephone as part of follow-up exclusion criteria: * patients will be excluded if treated with an influenza antiviral other than oseltamivir, including amantadine, rimantadine, or zanamivir. * suspected influenza is defined as an acute febrile illness characterized by the presence of fever and 1 or more of the following symptoms: cough, coryza/nasal congestion or sore throat.

Keywords: prospective, observational safety study
phase 1 study in patients with advanced solid malignancies to evaluate the safety of ator-1017

Conditions: Solid Tumor; Neoplasms

Summary: the aim of the study is to assess the safety and tolerability of increasing doses of ator-1017 when administered as repeated intravenous infusions to patients with advanced and/or refractory solid malignancies.


Eligibility criteria:
major inclusion criteria: a patient is eligible to be included in the study if all the following criteria apply: * has a diagnosis of advanced and/or refractory solid malignancy (histologically or cytologically documented) * has an eastern cooperative oncology group (ecog) performance status of 0 or 1 * has a minimum of one measurable tumor lesion * has acceptable hematologic and clinical chemistry laboratory values major exclusion criteria: a patient is excluded if any of the following criteria apply: * has not recovered from aes to at least grade 1 by ctcae version 5.0 due to prior anti-cancer medications * has symptomatic, steroid-dependent or progressive brain metastasis/metastases * has a history of another primary malignancy, except for: a) malignancy treated with curative intent and with no known active disease within 2 years prior to first dose of ator-1017, b) adequately treated non-invasive basal skin cancer or squamous cell skin carcinoma, c) adequately treated uterine cervical cancer stage 1b or less * has an autoimmune disorder requiring immune modulating treatment during the last 2 years * receives treatment with systemic immunosuppressant medication (except for inhaled and low dose systemic corticosteroids, i.e. ≤10 mg prednisolone or equivalent per day) * is a female patient who is pregnant or nursing
ar101 real-world open-label extension study

Conditions: Peanut Allergy

Summary: this study is enrolling participants by invitation only. this is an open-label, safety extension study for subjects who participated in the arc007 study.

this is a phase 3, multi-center, north american, open-label, long-term, safety extension study for eligible subjects who received ar101 therapy in the arc007 trial (nct03126227) and completed the study.

Eligibility criteria:
key inclusion criteria: * received ar101 in study arc007 * completed the arc007 study * use of effective birth control by sexually active female subjects of childbearing potential key exclusion criteria: * developed a clinically significant change in health status during the arc007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study. * receiving a prohibited medication or anticipated use of a prohibited medication \[e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers\], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy. * currently in the build-up phase of immunotherapy for any nonfood allergen. * currently participating in any other interventional clinical study outside of the arc007 study that was just completed.

Keywords: ar101 characterized peanut allergen cpna (characterized peanut allergen) oit (oral immunotherapy) peanut allergy peanut-allergic children desensitization food allergy
balance training for chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the study will involve direct knowledge translation of a laboratory-based study of balance training for patients with copd, first to the investigators pr program and then, after disseminating the results, this approach could be used to impact on clinical practice in any pr program.


Eligibility criteria:
inclusion criteria: * diagnosis of copd * self-report of decline in balance or fall in the last 5 years or a recent near fall * smoking history greater than 10 pack years * are able to provide written informed consent. exclusion criteria: * an inability to communicate because of language skills, hearing or cognitive impairment * evidence of a neurological or musculoskeletal condition that severely limits mobility and postural control (e.g., cerebrovascular accident, advanced parkinson's disease, amputation).

Keywords: copd balance pulmonary rehabilitation
autologel therapy to usual and customary care in pressure ulcers

Conditions: Pressure Ulcer

Summary: the aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort-controlled trial in which pressure ulcers will be treated using autologel and standard care and case-matched against a concurrent cohort of patients receiving undefined usual and customary care.

pressure ulcers (pus) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. autologel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. the results of autologel to date when used to treat pus have been promising. the aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which pressure ulcers will be treated using autologel and standard of care to determine time to heal at 16 weeks. comparison will be made with a case matched concurrent cohort of patients receiving undefined usual and customary care.

Eligibility criteria:
inclusion criteria: 1. medicare/medicaid eligible 2. ≥18 years of age 3. ulcer of pressure/shear etiology (stage ii, iii, and iv, see appendix 9 for stage definitions) 4. the largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) that is located on the heel, ischium, sacrum, and trochanter 5. for subjects with potentially multiple eligible pus, the largest ulcer will be selected. there must be at least 4 cm between the index ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure) 6. debrided ulcer size between 3 cm2 and 200 cm2 7. demonstrated adequate offloading regimen 8. duration ≥ 1 month at first visit 9. subject must be willing to comply with the protocol, which will be assessed by enrolling clinician. exclusion criteria: 1. subjects known to be sensitive to autologel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin 2. stage i pressure ulcers 3. ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound 4. presence of another wound that is concurrently treated and might interfere with treatment of index wound by autologel 5. ulcer not of pu pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology) 6. any malignancy other than non-melanoma skin cancer 7. subjects who are cognitively impaired and do not have a healthcare proxy 8. serum albumin of less than 2.5 g/dl 9. plasma platelet count of less than 100 x 109/l 10. hemoglobin of less than 10.5 g/dl 11. subject has inadequate venous access for repeated blood draw required for autologel administration. 10. life expectancy of \< 6 months.

Keywords: non healing wound pressure ulcer
phase 2 study for the treatment of superficial lipomas

Conditions: Lipoma

Summary: the purpose of this research is to compare the safety and effectiveness of 3 different concentrations of deoxycholic acid for injection against a placebo in the treatment of superficial lipomas.

a lipoma is a fatty lump typically located on the trunk, shoulder, arms, or legs. for the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)

Eligibility criteria:
inclusion criteria: * one or more lipomas, based on clinical and histological diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics: * history of slow growth followed by dormancy, and stable for at least 6 months * greatest length multiplied by greatest perpendicular width between 1 and 16 cm², inclusive * discrete, oval to rounded in shape, not hard or attached to underlying tissue * without changes in overlying skin (ie, inflammation, pain or tenderness, hyperpigmentation) * located on the trunk, arms, legs, or neck * signed informed consent. exclusion criteria: * absence of significant medical conditions that could affect safety * history of surgical or deoxycholate treatment for lipomas * treatment with an investigational agent within 30 days before atx-101 treatment
promybetaappgame: a study to learn more about the medication usage & patient reported outcomes via the mybetaapp and to find out more about the usage of game principles and game design elements (gamification) in medical care of patients with multiple sclerosis treated with betaferon

Conditions: Multiple Sclerosis

Summary: in this study researchers wanted to learn more about the medication usage behavior among multiple sclerosis (ms) patients treated with betaferon using the mybetaapp which includes the elements to what extent * taking medication matched the presciber´s recommendation (adherence, compliance), * treatment for the prescribed duration (persistence) was continued and * injections were missed. among ms patients treated with betaferon using the mybetaapp the study also collected information on the health-related quality of life, treatment satisfaction and satisfaction with treatment support.

the promybetaappgame study was a mixed prospective and retrospective, non-interventional, observational cohort study

Eligibility criteria:
inclusion criteria * patients aged ≥ 18 years. * patients on treatment with betaferon (every betaferon box contains a "mixject" number, which is a product specific number unrelated to the study. only patients prescribed betaferon for their ms will be able to use the mybetaapp and participate in the study). * patients must be using the mybetaapp. * electronic informed consent must be obtained. exclusion criteria - no exclusion criteria for participation in this study were defined.
trinav infusion system for the evaluation of fidelity between 99mtc-maa and y90-microspheres hepatic distribution for dosimetry treatment planning

Conditions: Liver Cancer

Summary: to learn if using the trinav infusion system (trinav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter.

primary objectives: to determine the percentage of tumors that demonstrate quantitative mean dose concordance (within 20%) using voxel-level quantitative spect/ct between 99mtc-maa treatment planning to post therapy y90 microspheres with an fda-cleared pressure enabled drug deliverytm (peddtm) device. secondary objectives: to determine the correlation of t:n ratios of all tumors 3cm based on 99mtc-maa spect/ct and y90 spect/ct imaging. to determine the fidelity and concordance of perfused normal liver uptake and distribution between 99mtc-maa treatment planning to post therapy y90 microspheres spect/ct. to assess safety of trinav catheter in this study population

Eligibility criteria:
inclusion criteria: * patients over 18 years of age, of any race or sex, who have unresectable primary or metastatic tumors of the liver, and who are able to give informed consent. * patients must be eligible for y90-radioembolization treatment, have an ecog performance status score of ≤ 2, with a life expectancy of ≥ 3 months, and must be non-pregnant with an acceptable contraception in premenopausal women. * at least one lesion ≥ 3.0 cm in shortest dimension * negative pregnancy test in premenopausal women exclusion criteria: * contraindications to angiography and selective visceral catheterization * evidence of potential delivery of greater than 30 gy absorbed dose to the lungs with a single injection. * evidence of any detectable tc-99m maa flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels) * infiltrative tumors * target vessel sizes outside of trinav device prescribed diameter range of 1.5 - 3.5 mm